Functional RNA Content
Context in Practice: Example Specifications
From Specification: Typical mRNA (Drug Substance) Specifications
- Rationale: Confirms presence of reverse-transcribable, structurally intact mRNA. Provides orthogonal, transcript-specific measure of RNA content and quality.
- Acceptance Criteria: Comparable to qualified reference standard; Product-specific acceptance range established during development (e.g., 80–120% relative to reference standard).